About this trial
Surgical site infections (SSIs) are associated with increased patient morbidity, mortality, and healthcare costs. ESKAPE (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) pathogens are particularly pathogenic because they have increased capacity to acquire resistance and virulence traits. The investigators have proven that a multifaceted program involving improved basic perioperative preventive measures can generate substantial reductions in S. aureus transmission and significant reductions in SSIs (88% reduction as compared to usual care). In this study, the investigators aim to examine the relative effectiveness of each component of this program in controlling ESKAPE transmission and reducing SSIs and to identify an optimal implementation strategy for national dissemination. Randomization occurs at the site level, and sites adopt preventative programs. This work will improve perioperative patient safety for the 51 million patients who undergo surgery each year.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
250 patients (125 case pairs) per site in the active phase (N=3,000)
250 patients (125 case pairs) per site in the sustainability phase (N=3,000)
Total N=6,000
orthopedic total joint and spine procedures
Trial design
Factorial
Treatments tested in this trial
Technical assistance or team-based coaching
BehavioralMain comparison in delivering peri-operative preventive strategies against transmission and infection is one on one technical assistance or team-based coaching.
Treatment groups
Trial outcomes
Primary outcomes
ESKAPE Transmission Events
One or more epidemiologically related ESKAPE pathogen transmission events (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, Enterobacter spp.) occurring in a perioperative observational unit. ESKAPE transmission will be defined as ≥ 2 ESKAPE isolates of the same class obtained from ≥ 2 distinct, temporally-associated reservoirs and/or the isolation of ≥ 1 ESKAPE pathogen from a reservoir at case end that was not present at case start, a definition tightly associated with SSI.
Secondary outcomes
Surgical Site Infection
90 postoperative day SSIs according to the NHSN SSI checklist. SSI tracking will initially involve chart review for fever, leukocytosis, culture (type/source), anti-infective order, office documentation of infection, and up to 3 calls in the 90-day postoperative period. If 1 or more of the 5 criteria are flagged and/or documentation by phone call as recorded in the microEMR, the site PI reviews the information and applies to NHSN checklist criteria for SSIs. Superficial incisional, deep incisional, and organ/space SSIs will be tracked. Information will be compiled in a separate spreadsheet without treatment group identifiers for blinded review.
Sponsors and contacts
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